Vaccine Recalls
The U.S. Food and Drug Administration (FDA) and its Center for Biologics Evaluation and Research monitors vaccines as part of its Vaccines, Blood and Biologics initiative. The goal of monitoring vaccines is to protect both adults and children from adverse reactions to vaccines.
The FDA establishes the regulations for vaccine manufacturing, testing and record keeping, and the packaging and distribution of vaccines. It also oversees vaccine recalls when the situation warrants. Vaccine testing results for specific lots must be submitted to the FDA for review, and the FDA determines if the vaccine is safe for distribution. Vaccine manufacturers and health care providers are required to report adverse events promptly to the FDA.
Vaccine recalls require the manufacturer to remove or correct a product that is already on the market as soon as the FDA determines that the product is in violation. In late 2009 and early 2010, one of the largest vaccine recalls involved both removal and field correction of the 2009 H1N1 Influenza Monovalent Vaccine.
Pharmaceutical companies must maintain recall plans and test their recall procedures to ensure recall compliance under stringent FDA regulation and oversight. Like any pharmaceutical recall, a vaccine recall must be managed quickly and effectively in order to protect the public and preserve the company’s reputation for safety and regulatory compliance.
For more information, visit www.fda.gov.
